Zecuity

1 What is Zecuity?

Brand: Zecuity

Generic: Sumatriptan Transdermal

Zecuity is used to treat acute migraineheadaches with or without aura in adults. It is not used to prevent migraine headaches. Sumatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

Many people find that their headaches go away completely after they use sumatriptan transdermal. Other people find that their headaches are much less painful and that they are able to go back to their normal activities even though their headaches are not completely gone.

Zecuity often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Zecuity is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Zecuity has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the benefits that it can have.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

2 What to Know Before Using

Before using Zecuity, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Although appropriate studies on the relationship of age to the effects of sumatriptan transdermal have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine. This medicine should not be used by elderly patients with severe liver problems.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding:Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

Raynaud's syndrome—Use with caution. May be at increased risk for certain side effects. Heart or blood vessel disease sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use this medicine, your doctor may need to do some tests to make sure that you do not have any of these conditions

Seizures, history of—Use with caution. May make these conditions worse

3 Proper Usage

To use Zecuity properly, you must follow all instructions given by your doctor. Do not use this medicine for a headache that is different from your usual migraines. Talk to your doctor about what to do for regular headaches.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

Zecuity™ is an iontophoretic transdermal system (TDS) or a device-assisted skin patch that uses a mild electrical current to deliver sumatriptan through your skin.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the Zecuity™ patch:

Use this medicine exactly as directed by your doctor. It will work only if it has been applied correctly.

This medicine should only be used on skin that is not irritated or injured. Do not put the patch in your mouth, chew it, or swallow it.

Sumatriptan skin patches are packaged in sealed pouches. Do not use this medicine if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.

Wash your hands with soap and water before and after applying a patch.

To apply the patch, pull the two foil tabs and rub each foil packet tracing the green arrow 3 times around. Unfold and lift open the package. Slowly peel the liner and check if the medication pads are securely attached.

Apply the patch to a dry, intact, flat skin area on your upper arm or thigh. Choose a place where the skin is not very oily and is free of scars, tattoos, cuts, burns, scratches, or irritation. The application site should be free from redness or irritation for at least 3 days before applying a new patch.

The patch will stay in place better if it is applied to an area with little or no hair. If you need to apply the patch to a hairy area, you may first clip the hair with scissors, but do not shave it off.

After applying the patch, push the activation button and a red light emitting diode (LED) will turn on. The patch must be applied and activated within 15 minutes after removing the foil tabs.

If the patch becomes loose, tape the edges with a medical tape.

If the activation light turns off before 4 hours, the patch can be removed. Remove it slowly to avoid skin irritation. Clean the area gently with a mild soap and water to remove any medicine left on the skin.

Keep the patch dry. Do not bathe, shower, or swim while using this medicine.

If your headache comes back or gets worse after a while, you may apply a second patch to your other arm or thigh and wait for at least 2 hours after activation of the first applied patch.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Adults—One patch applied to the skin and left in place for 4 hours. Do not use more than two Zecuity™ patches in a 24-hour period.

Children—Use and dose must be determined by your doctor.

Missed Dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

This medicine contains lithium-manganese dioxide batteries. Talk to your doctor or pharmacist about how to follow state and local regulations when throwing away this medicine.

To dispose of this medicine, fold the patch in half with the sticky side inside. Then throw it properly in a trash can.

4 Precautions to Take

Before using Zecuity, there are some precautions you must take. It is very important that your doctor checks your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

You should not use this medicine if you have used a MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), or tranylcypromine (Parnate®) within the past 2 weeks.

Check with your doctor if you have used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often. Also, using this medicine too often may make your headache worse (medication overuse headache). Keep a headache diary to record your headache frequency and drug use.

Tell your doctor right away if you have to blister, burning, crusting, dryness, flaking of the skin or itching, scaling, severe redness, soreness, swelling of the skin after using this medicine. These could be symptoms of a condition called allergic contact dermatitis.

This medicine may cause problems if you have heart disease. If your doctor thinks you might have a problem with this medicine, he or she may want you to use your first dose in the doctor’s office or clinic.

This medicine may increase your risk of having a heart attack, angina, or stroke. This is more likely to occur if you have diabetes, high blood pressure, or high cholesterol, or if you already have a heart disease or a family history of heart disease, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause.

Call your doctor right away if you have any symptoms of a heart problem, such as:

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting.

Other signs may include changes in the color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Before having a medical procedure (such as magnetic resonance imaging or MRI), you must remove the patch because it contains metal parts. Also, do not apply the patch near body areas with medical devices (e.g., implantable cardiac pacemaker, body-worn insulin pump, implantable deep brain stimulator).

Some people feel dizzy or drowsy during or after a migraine, or using sumatriptan to relieve a migraine. As long as you are feeling dizzy or drowsy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

Redness, pain, itching, or skin rash where the patch is applied

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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